Gingival DiseasesPhase 3NCT00763048

Collection of Gingival Crevicular Fluid From Periodontitis Patients

A Phase 3 study testing Fluoride and Fluoride, triclosan in people with Gingival Diseases, run by Colgate Palmolive at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis. Read more about this study

Who is it for?: Ages 26 to 68 yearsHealthy volunteers can take part
Conditions the study is for: Gingival Diseases
What is being tested?: Fluoride and Fluoride, triclosan
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Apr 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 26 to 68 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be aged 18 to 65 years inclusive
Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
Give written informed consent
Be in good general health
No known history of allergy to personal care/consumer products or their
ingredients, relevant to any ingredients in the test products as determined by the
dental/medical professional monitoring the study

Who cannot join

Medical condition which requires pre-medication prior to dental visits/procedures
Advanced periodontal disease
5 or more decayed, untreated dental sites
Diseases of the soft or hard oral tissues
Orthodontic appliances
Abnormal salivary function

Show all 14Show fewer

Use of prescription drugs.
Use of antibiotics one (1) month prior to or during this study
Use of any over the counter medications other than analgesics
Erratic use of vitamin supplements
Pregnant or breastfeeding.
Participation in another clinical study in the month preceding this study
Allergic to common dentifrice ingredients
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Trial locations and contacts

1 site in 1 country.

United States1 site

Forsyth Institute
Boston, Massachusetts, 02115

Other trials in United States

About this study

To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.

Conditions: Gingival Diseases
Being tested: Fluoride, Fluoride, triclosan
Medical subject headings: Gingival Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FluorideDrug
Also called Coglate Great Regular Flavor toothpaste
Brush twice daily for 6 weeks
Fluoride, triclosanDrug
Also called Colgate Total toothpaste
Brush twice daily

Study groups in NCT00763048
Study group	Role	What they receive
A -Control	Placebo comparator	Fluoride toothpaste (Colgate Great Regular Flavor) is the control for this study. All study toothpastes contain fluoride. The study is evaluating the additional ingredients in the other toothpastes. Receives: Drug: Fluoride
B	Active comparator	fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste) Receives: Drug: Fluoride, triclosan

What is being measured

The primary outcome is the main question the study is designed to answer.

Metabolite Associated With Inflammation (Cadaverine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Measured: 6 weeks
Metabolite Associated With Inflammation (Choline)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Measured: 6 weeks
Metabolite Associated With Inflammation (Hypoxanthine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Measured: 6 weeks
Metabolite Associated With Inflammation (Inosine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Measured: 6 weeks
Metabolite Associated With Inflammation (Isoleucine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Measured: 6 weeks
Metabolite Associated With Inflammation (Leucine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Measured: 6 weeks
Metabolite Associated With Inflammation (Lysine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Measured: 6 weeks
Metabolite Associated With Inflammation (Phenylalanine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Measured: 6 weeks
Metabolite Associated With Inflammation (Putrescine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Measured: 6 weeks
Metabolite Associated With Inflammation (Xanthine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Apr 2008

First posted30 Sep 2008 (estimated)
Study startMar 2008
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gingival DiseasesStudies of the same condition, open and under way.
More trials run by Colgate PalmoliveThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00763048
Sponsor's protocol ID: CRO-2007-GIN-05-GB
Status last verified: Jun 2011
First submitted: 26 Sep 2008
Last updated: 14 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Gingival Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Collection of Gingival Crevicular Fluid From Periodontitis Patients
ClinicalTrials.gov ID: NCT00763048
Acronym / sponsor ID: CRO-2007-GIN-05-GB
Conditions: Gingival Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 1 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
A -Control	Placebo comparator	Drug: FluorideFluoride toothpaste (Colgate Great Regular Flavor) is the control for this study. All study toothpastes contain fluoride. The study is evaluating the additional ingredients in the other toothpastes.
B	Active comparator	Drug: Fluoride, triclosanfluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)

Who may qualify

Ages: 26 to 68 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Be aged 18 to 65 years inclusive
Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
Give written informed consent
Be in good general health
No known history of allergy to personal care/consumer products or their

Key exclusion criteria (14 listed)

Medical condition which requires pre-medication prior to dental visits/procedures
Advanced periodontal disease
5 or more decayed, untreated dental sites
Diseases of the soft or hard oral tissues
Orthodontic appliances

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FluorideAlso: Coglate Great Regular Flavor toothpasteBrush twice daily for 6 weeks	Drug	A -Control
Fluoride, triclosanAlso: Colgate Total toothpasteBrush twice daily	Drug	B

Primary outcome

Metabolite Associated With Inflammation (Cadaverine)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Choline)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Hypoxanthine)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Inosine)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Isoleucine)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Leucine)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Lysine)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Phenylalanine)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Putrescine)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Metabolite Associated With Inflammation (Xanthine)
Time frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.

Results and safety

Results posted to the registry on 1 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A - Control Comparator	21	21
B - Active Comparator	18	18

Primary outcome: Metabolite Associated With Inflammation (Cadaverine)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: ion count

Measure	A - Control Comparator n = 21	B - Active Comparator n = 18
Value	1.119186 (0.834969)	0.92077 (0.78476)

A - Control Comparator vs B - Active Comparator: p <0.05, t-test, 1 sided

Primary outcome: Metabolite Associated With Inflammation (Choline)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: ion count

Measure	A - Control Comparator n = 21	B - Active Comparator n = 18
Value	1.2264 (0.79066)	1.169513 (0.79071)

A - Control Comparator vs B - Active Comparator: p <0.05, t-test, 1 sided

Primary outcome: Metabolite Associated With Inflammation (Hypoxanthine)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: ion count

Measure	A - Control Comparator n = 21	B - Active Comparator n = 18
Value	0.76984 (0.58459)	0.701628 (0.63887)

A - Control Comparator vs B - Active Comparator: p <0.05, t-test, 1 sided

Primary outcome: Metabolite Associated With Inflammation (Inosine)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: ion count

Measure	A - Control Comparator n = 21	B - Active Comparator n = 18
Value	1.11183 (1.05685)	0.84462 (0.99409)

A - Control Comparator vs B - Active Comparator: p = 0.05, t-test, 1 sided

Adverse events

Time frame: 7 weeks (1 week washout period + 6 week study treatment period). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A - Control Comparator	0 of 21 (0%)	0 of 21 (0%)	Not reported
B - Active Comparator	0 of 18 (0%)	0 of 18 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Riccardo Teles, DMD principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluoride and Fluoride, triclosan in people with Gingival Diseases, run by Colgate Palmolive at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolite Associated With Inflammation (Cadaverine) (time frame: 6 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00763048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.